The following data is part of a premarket notification filed by Jms North America Corporation with the FDA for Jms Sysloc Mini A.v. Fistula Needle Set (v4), Jms Sysloc Mini Apheresis Needle Set (v4).
| Device ID | K142564 |
| 510k Number | K142564 |
| Device Name: | JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) |
| Classification | Needle, Fistula |
| Applicant | JMS North America Corporation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 |
| Contact | Sho Hosoki |
| Correspondent | Sho Hosoki JMS North America Corporation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-11 |
| Decision Date | 2014-12-23 |
| Summary: | summary |